Moderate to severe plaque psoriasis in adults
Conditions
Interventions
QX001S versus ustekinumab:QX001S injection, 45 mg (0.5 mL, QX001S, 45 mg (0.5 mL), Ustekinumab 45 mg (0.5 mL), 45 mg (0.5 mL)
Sponsors
JiangSu Qyuns Therapeutics Co., Ltd
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent before the test, and fully understand the content, process and possible adverse reactions of the test. 2. Ability to comply with the requirements of this trial protocol. 3. Subject has no pregnancy plan in the following 6 months (during the trial) and voluntarily adopts effective contraceptive measures . 4. Male adult between 18 and 50 years of age inclusive, at the time of signing the informed consent. 5. Body weight of male adult = 50 kg and =85 kg , Body mass index (BMI) within the range 18–28 kg/m2 (inclusive) BMI(kg/m2) = body weight(kg)/{height(m)}2 6. physical examination, vital signs were normal or abnormal judgment by a doctor without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Those who smoked more than five cigarettes a day three months before the trial; 2. After inquiry, suspected or confirmed as allergic constitution (allergic to a variety of drugs and food), allergic to test drug allergies; 3. With a history of drug abuse and/or alcohol abuse (drinking more than 14 units of alcohol per week in the first six months of screening (1 unit of alcohol = 285 mL beer or 25 mL spirits or 100 mL wine); 4. Blood donation or massive blood loss (>450 mL) within 3 months prior to the use of the study drug, or planned blood donation or planned surgery during the study period; 5. Have any disease that increases the risk of bleeding; 6. Any prescription, over-the-counter, vitamin products or herbs were used 28 days before the use of the research drug; 7. Significant changes in diet or exercise habits were observed 2 weeks before the trial or after the screening; 8. Those who have participated in clinical trials of any drug or medical device within three months before the use of the research drug are still in the follow-up period of a clinical study; 9. Abnormal electrocardiogram has clinical significance; 10. Clinical laboratory examinations have abnormal clinical significance, or other clinical findings within the first six months of screening show clinical significance of the following diseases (including but not limited to gastrointestinal, renal, liver, nerve, blood, endocrine, tumors, lung, immune, mental or cerebrovascular diseases); 11. There was a history of invasive systemic fungal infection or other opportunistic infection within 2 months before screening; 12. There were systemic or local infections within 2 months before screening, such as the risk of sepsis and/or known active inflammation; CRP levels were higher than the 1.5x normal upper limit during screening or baseline; 13. Hepatitis B (including hepatitis B and C), AIDS and syphilis were screened positive; 14. Acute diseases occur at the screening stage before the study or before the study of medication; 15. Any alcoholic product was taken within 24 hours before the study drug was administered; 16. Alcohol and drug positive screeners or drug abusers who had a history of drug abuse in the past five years or used drugs three months before the trial; 17. Any biological products were used within 3 months before screening; 18. Any immunoglobulin biologicals were used in the first year of screening; 19. TNF and interleukin cytokine targeting agents have been used; 20. Cannot or unwilling to undergo repeated venipuncture (for example, due to poor tolerance or lack of venous access); 21. Those who receive live (attenuated) vaccines within 12 weeks before screening or who plan to receive live (attenuated) vaccines during screening and research visits; 22. Those who plan to receive any biological drug or monoclonal antibody drug within three months or nine months after the administration of the experimental drug; 23. Employees or related personnel of researchers, research centres, bidders and contractual research organizations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indices; | — |
Countries
China
Contacts
Public ContactDing Yan-Hua
the First Hospital of Jilin University
Outcome results
None listed